Kornimate/medical-research-clean huggingface dataset:
incisional wound vac in obese patients

Conditions: Wound Infection; Postoperative Complication

Summary: it is the belief of the investigators that the current trends in complication rates associated with fixation of pelvic ring injuries and acetabular fractures in the obese are unacceptable. the overwhelming majority of these complications can be attributed to problems with surgical wound healing. the investigators feel that if a cost effective and easily performed intervention can be prospectively utilized in a specific at-risk orthopaedic trauma population in order to control a potentially devastating complication, then efforts in discovering such an intervention may prove valuable. it is our hypothesis that obese patients treated with v.a.c. therapy after standard closure of trauma-related, operative orthopaedic incisions will have fewer postoperative wound complications.

obesity has been shown to be an independent risk factor for postoperative surgical infections in a variety of obesity related and non-obesity related surgeries. with the risk of an increasingly more obese society, complication rates that significantly differ based on patients' relative obesity may become increasingly unacceptable. the purpose of the proposed prospective study is to evaluate the role that vacuum assisted closure (vac) may play in reducing these complication rates. negative pressure or vacuum assisted closure was first introduced in 1997 as a way to control and potentially treat chronic wounds. since that time, the indications have exploded to include a variety of chronic and acute wound healing problems. we have anecdotally been using vac therapy (v.a.c.;kci, san antonio, texas) in an effort to control the postoperative draining that is nearly ubiquitous in our morbidly obese orthopaedic trauma patients. the v.a.c. dressing is applied to the acute postoperative wound and maintained during the immediate postoperative period. although a novel approach to the use of the v.a.c., this use has been previously reported in the orthopaedic literature as a case series. to our knowledge, there has not been a prospective study evaluating the efficacy of the immediate placement of a v.a.c. dressing on postoperative wound infection rates in the setting of the morbidly obese orthopaedic trauma patient. it is our hypothesis that obese patients treated with v.a.c. therapy after standard closure of trauma-related, operative orthopaedic incisions will have fewer postoperative wound complications.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18 - 64 * patients with a bmi greater than or equal to 30 * patients with acetabular, pelvic ring, or proximal femur fractures with a degree of displacement that would require an open reduction for treatment under normal circumstances exclusion criteria: * patients not within variables defined by the inclusion criteria * abdominal or urological surgery during the same hospital admission * ipsilateral soft tissue injuries that can be classified as internal degloving injuries

Keywords: fracture fixation, internal obesity pelvis negative pressure wound therapy vacuum-assisted closure
comparison of the operation and medical treatment of endometriosis and adenomyosis

Conditions: Endometriosis; Adenomyosis

Summary: endometriosis (including adenomyosis) is one of the most common gynecological diseases among women of childbearing age. common symptoms such as menstrual pain, excessive menstrual flow, infertility, chronic lower abdominal pain, and painful intercourse. according to the literature statistics, the prevalence of endometriosis in women of childbearing age is about 10-20%, while the prevalence of adenomyosis is about 5%. traditional medical treatments include hormones (danazol, gestrinone, oral lutein). oral contraceptive, there is a gonadotropin-releasing hormone agonist in the injection form, and a levonorgestrel-releasing intrauterine system in the intrauterine administration system. the choice of drugs has many influencing factors, such as the severity of endometriosis in patients (according to the classification of the american society for reproductive medicine), the need for fertility, the convenience of drug use, and the patient's tolerance to drug side effects. surgery is also one of the treatment options for endometriosis and adenomyosis, including traditional open or minimally invasive endoscopic ovarian cyst resection, oophorectomy, and lesion resection; adenomyosis surgery includes traditional methods open abdominal, transvaginal or minimally invasive endoscopic hysterectomy, conservative uterine sparing adenomyomectomy and cytoreduction surgery (partial adenomyomectomy). for endometriosis, the common treatment consensus of obstetricians and gynecologists is to follow the surgical treatment of the lesions and then follow-up medication. for women with adenomyosis, if they have completed the birth, it is recommended to have a total hysterectomy, so that there is no recurrence. the possibility. however, for women who have not completed birth, conservative uterine preservation surgery is performed. according to research statistics, endometriosis or adenomyosis does not receive follow-up medical treatment after completion of surgical treatment, there is a high probability of recurrence, but the side effects caused by drugs will also affect the patient's compliance with medication.the department of women's medicine of the hospital has a wealth of experience in the treatment of endometriosis and adenomyosis. each year, about 500 cases of endometriosis (including adenomyosis) are performed. this study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments.

the main purpose: to analyze the prognosis and treatment effect of endometriosis and adenomyosis after surgery and drug treatment. secondary objective: analysis of endometriosis and adenomyosis after surgery and medication, the patient's assessment of drug side effects.

Eligibility criteria:
inclusion criteria: * patients who underwent endometriosis or adenomyosis-related surgery in the investigator's hospital from 2005/01/01 to 2018/12/31, and received follow-up medication. exclusion criteria: * none
prevention of postpartum haemorrhage with sublingual misoprostol or oxytocin

Conditions: Postpartum Hemorrhage

Summary: sublingual misoprostol produces rapid peak concentration and is more effective than oral misoprostol for prevention of excessive postpartum bleeding. the study hypothesis was to test whether women receiving sublingual misoprostol for prevention of postpartum hemorrhage have 30 ml less average blood loss than women receiving oxytocin, the standard of care for prevention of postpartum hemorrhage. we conducted a double blind randomized controlled trial of .652 consenting, eligible pregnant women admitted to the labor room of the teaching hospital at j n medical college, belgaum, india. women participating in the study were assigned by computer generated randomization to receive the study medications and placebos within one minute after clamping and cutting the umbilical cord. we also looked at the drugs effects on postpartum blood loss at or above ≥500 ml (considered hemorrhage), and the percent of women experiencing more than a 10% decline in haemoglobin, and reported drug side effects.


Eligibility criteria:
inclusion criteria: * women with a gestational age \>28weeks * singleton pregnancy with cephalic presentation anticipating a normal spontaneous vaginal delivery (including episiotomy) * a haemoglobin ≥ 8g/dl upon presentation who were admitted to labour room in the kle teaching hospital attached to j n medical college, belgaum exclusion criteria: * women with pregnancy induced hypertension * antepartum haemorrhage * previous caesarean section or presence of uterine scar * diagnosed chorioamnionitis * oxytocin induction or augmentation of labour * intrauterine death * diagnosed medical disorders (such as diabetes, cardiac, renal and hepatic diseases, etc.) or those in active labour (defined as \>4 cm dilatation)

Keywords: misoprostol, oxytocin, postpartum blood loss, hemoglobin
montelukast in mild asthmatic children with allergic rhinitis (0476-367)

Conditions: Asthma; Allergic Rhinitis

Summary: the purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.


Eligibility criteria:
inclusion criteria: * between 2 and 14 years old * diagnosed with asthma, classified as mild persistent asthma according to global initiative asthma guidelines (gina) * diagnosed with comorbid allergic rhinitis exclusion criteria: * patients with suspected sinus infection * prior treatment with high dose inhaled corticosteroid requiring a dose higher than beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in severe cases
to evaluate the efficacy and safety of abcd in the treatment of ifd

Conditions: Invasive Fungal Disease

Summary: in order to better guide clinical medication, verify the efficacy and safety of abcd in the treatment of various invasive fungal disease, the investigators have designed a multi-center, retrospective registration study. diagnosis and treatment data for patients with different types of invasive fungal disease in clinical actual environment was collapsed by a database for collaborative exchange on antifungal research.

this study is a retrospective, non-interventional, and observational study. the clinical data of the patient during hospitalization shall be collected at least 2 weeks after the end of the abcd drug, including basic data of the patient, laboratory data and clinical treatment, mainly covering antifungal medications, such as pretreatment measures, drug dosage and dispensing method, route of administration, duration of administration, efficacy and adverse reactions, etc. if adverse events related to abcd have not ended after 2 weeks, investigators are advised to follow up until the adverse events recover or stabilize. it is hoped that the basic situation of chinese invasive fungal patients is described, and abcd is evaluated in the treatment of invasive fungal patients. in addition, prognostic factors can be analyzed to optimize clinical medication regimen and provide basis support for clinical medication of abcd.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years. 2. patients with possible/probable/proven invasive fungal disease according to eortc-msg diagnostic criteria. 3. patients received abcd alone or in combination with other antifungals on either empirical, diagnosis-driven or targeted therapy. 4. there is no limit to the patient's previous treatment plan. exclusion criteria: 1. patients judged by clinicians to be unsuitable for this study. 2. patients with incomplete data or other factors affecting the judgment of efficacy and safety.

Keywords: amphotericin b colloidal dispersion invasive fungal disease
modern hybrid imaging in patients with oscc

Conditions: Neoplasm

Summary: prospective diagnostic study to determine the diagnostic accuracy of preoperative 18f--fluorodeoxyglucose (fdg) positron emission tomography/computed tomography (pet/ct) in detecting local tumor extent, cervical lymph node metastases and distant metastases/secondary primary tumor.


Eligibility criteria:
inclusion criteria: * histopathological proven head and neck carcinoma * written inform consent * 18 years of age exclusion criteria: * cancer of unknown primary * en-bloc resection of lymph node levels * uncertainties regarding the removed lymph node levels

Keywords: head and neck scc pet/ct staging
phase ii study of intravenous novantrone(r) in the treatment of aids related kaposi's sarcoma

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: to study the toxicity and efficacy of iv mitoxantrone hydrochloride (novantrone) in aids-related kaposi's sarcoma.


Eligibility criteria:
inclusion criteria patients must have the following: * biopsy proven kaposi's sarcoma in advanced stages. * positive hiv antibody, hiv culture or antigen capture or t4 cells \< 500 in a patient with aids risk factor. * informed consent and availability for follow-up. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * uncontrolled opportunistic infection. * any medical, surgical or psychiatric condition which would constitute a contraindication to the use of mitoxantrone. concurrent medication: excluded: * zidovudine (azt). patients with the following are excluded: * uncontrolled opportunistic infection. * unable to give informed consent. * any medical, surgical or psychiatric condition which would constitute a contraindication to the use of mitoxantrone. prior medication: excluded: * more than one form of chemotherapy regimen. * doxorubicin therapy \> 300 mg/m2. prior treatment: excluded: * previous therapy consisting of more than one modality of therapy (e.g., chemotherapy plus radiotherapy or more than one form of chemotherapy regimen.)

Keywords: mitoxantrone acquired immunodeficiency syndrome
effects of dietary intervention and surgery on nafld (non-alcoholic fatty liver disease)

Conditions: Non-Alcoholic Fatty Liver Disease; Non Alcoholic Fatty Liver; Bariatric Surgery Candidate; Obesity, Morbid

Summary: approximately 90% of people undergoing bariatric surgery have nafld, which is a condition where fat accumulates in the liver and can lead to inflammation and scarring. it mostly causes no symptoms, however, in the most advanced cases there is an increased risk of liver cancer or liver failure. nafld is currently managed by weight loss and treating associated diseases such as diabetes. no medicines have been licensed to directly treat it but bariatric surgery has been shown to be usually beneficial, although it is unknown whether some operations are better than others. it is also unclear whether this is due to general weight loss or other factors. this study will be conducted in a hospital setting and aims to determine what changes in liver fat and fat processing occur after pre-operative low calorie diet and the two most common types of bariatric surgery (roux-en-y gastric bypass and sleeve gastrectomy. participants will have ten study visits, four of which may be combined with nhs appointments. participants will undergo investigations including mri scans to measure changes in nafld and dexa scans to measure changes in fat and fat-free mass (ffm). participants will also undergo mixed meal testing to which stable isotopes (deuterated water and 13c-palmitate) will be added to allow changes in fat processing to be detected. in addition to samples taken as part of nhs care, blood, urine, liver and fat (visceral and subcutaneous (abdominal and gluteal)) will be used for research. visits will take place before and after low calorie diet and bariatric surgery.


Eligibility criteria:
inclusion criteria: * bariatric surgery is already planned for the participant * participant is willing and able to give informed consent for participation in the study. * aged ≥18 or ≤75 years. * body mass index ≥35 ≤55 kg/m2 exclusion criteria: * contraindication to mri * prior or current participation in a ctimp that could affect study results * history of alcoholism or a greater than recommended weekly alcohol intake (14 units per week) * history of albumin allergy * anticoagulant treatment * pregnant or nursing mothers * type 2 diabetes * a liver disease other than nafld * histological confirmation of lack of nafld on liver biopsy * large hiatus hernia (that would prohibit sleeve gastrectomy) * active gastrooesophageal reflux disease (that would prohibit sleeve gastrectomy) * active malabsorptive intestinal disease (that would prohibit roux-en-y gastric bypass surgery)

Keywords: non-alcoholic fatty liver disease bariatric surgery
losartan and hctz and amlodipine vs atenolol and amlodipine (0954a-309)(completed)

Conditions: Hypertension

Summary: a study to evaluate the effects of combination losartan versus combination atenolol in patients with ambulatory systolic hypertension.


Eligibility criteria:
inclusion criteria: * males or females at least 18 years of age who have ambulatory systolic hypertension.
a observational study to evaluate lipid-lowering drug its effect on parameters in dyslipidemia of type 2 diabetes.

Conditions: Complex Dyslipidemia

Summary: 1. target disease: patients with combined dyslipidemia accompanied by type 2 diabetes who has done exogenous visit or hospitalization from jan 2010 to june 2014. 2. study objective: 1. the objective of this study is to identifying the lipid parameter variation when treating patients who have dyslipidemia of type 2 diabetes for 3±1 months. 2. after treating patients who have dyslipidemia of type 2 diabetes for 3±1 months, identifying the reason why changing method of drug dosage and pharmacotherapy. 3. if the drug dosage and pharmacotherapy have been changed, identifying the lipid parameter variation when treating patients by altered drugs for 3±1 months,


Eligibility criteria:
inclusion criteria: among the patients, who has been hospitalized or visited the outpatient department opd, who has dyslipidemia of type 2 diabetes. 1. patients have the result of lipid parameter test at baseline and after lipid-lowering drug for at least 3 months. 2. patients who have the result of lipid paraneter test (ldl-c ≥100mg/dl, tg ≥150mg/dl) at baseline. 3. patients who have no received lipid lowering drug fr at least 2 months prior to the baseline. 4. patients' age were \> 20 years and \<75 year. exclusion criteria: 1. patients who ahs hba1c≥9% 2. patients who have no the result of lipid parameter test at baseline and at baseline and after lipid-lowering drug for at least 3 months 3. patients who have history of drug discontinuation by incresed liver enzyme or rhabdomyolysis. 4. patients received lipid-lowering drug and tzd(thiazolidinediones) in study period 5. renal abnormality 6. alcoholism or alcohol abuse 7. patients treated by steroids. 8. pregnant or lactating woman 9. patients who are judged as not suitable for this study by investigator.
sublocade long-term outcomes

Conditions: Opioid Use Disorder

Summary: this study will provide the opportunity to generate data on the long-term use of sublocade under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the recovery process. long-term patterns of abstinence/opioid misuse as well as measures of participants' physical, psychological, social, and economic well-being will be monitored to better understand factors associated with recovery from opioid use disorder (oud). therefore, this study will observe participants up to a maximum of 4 years.

this is a phase iv, prospective, multicentre, multinational, open-label, real-world observational study in participants with current or a history of oud/opioid dependence.

Eligibility criteria:
inclusion criteria: participants must meet all of the following criteria: * is an adult ≥ 18 years of age who has signed the informed consent form * plans to receive additional sublocade injections and * has initiated treatment for oud/opioid dependence with sublocade within the last 3 months prior to baseline visit * or * has completed an indivior sublocade study (eg, indv-6000-401, indv-6000-405) and has received the last dose of sublocade on that study within 3 months prior to baseline visit * is not currently participating in any clinical trial requiring medical intervention * is not currently using opioids to treat a diagnosis other than oud/opioid dependence

Keywords: medicine for opioid use disorder (moud)
study of medi-573 plus standard endocrine therapy for women with hormone-sensitive metastatic breast cancer

Conditions: Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer

Summary: study to evaluate the safety, tolerability, antitumor activity, and pharmacology of medi-573 in combination with an aromatase inhibitor (ai) in adult subjects with hr+, her2-negative mbc.

this is a phase 1b/2, multicenter, open-label study to evaluate the safety, tolerability, antitumor activity, and pharmacology of medi-573 in combination with an ai in adult subjects with hr+, her2-negative mbc. this study has 2 phases: a dose-evaluation phase (phase 1b) and a randomization phase (phase 2).

Eligibility criteria:
inclusion criteria: * histologically-confirmed mbc not deemed amenable to curative surgery or curative radiation therapy * tumors are positive for er, pgr, or both * tumors must be negative for her2 (by fish, cish or ihc) * female gender and age ≥ 18 years at time of study entry * postmenopausal * karnofsky performance status ≥ 70 * life expectancy of ≥ 6 months exclusion criteria: * subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions: * prior adjuvant therapy with an ai and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of medi-573 * prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed * extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy) * active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of cns progression for at least 4 weeks of first dose of medi-573 * evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis * unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to ≤ grade 1 at the time of starting study treatment * previous treatment with agents that target the igf receptor * history of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of medi-573 or ai * history of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix * poorly controlled diabetes mellitus

Keywords: medi-573, breast cancer, metastatic, aromatase inhibitor, anti-igf